Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades
FDA 510(k) K100669 · Us Medical Innovations, LLC
510(k) numberK100669
Submission
- Device name
- Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades
- Applicant
- Us Medical Innovations, LLC
Austin, TX, US - Received
- March 9, 2010
- Decision date
- April 6, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades cleared by the FDA?
Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades (K100669) received a 510(k) decision of Substantially Equivalent on April 6, 2011, 393 days after the submission was received.
What is the product code of K100669?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.